BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSONIC

    MDR report key: 11789671 · Received May 7, 2021

    Report

    Report Number
    11789671
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 30, 2021
    Manufacturer
    TRANSONIC SYSTEMS INC.
    Product Code
    DPW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO LOW FLOW ALARMS TRIGGERED BY R IJ ECMO FLOW PROBE. ALARM ISSUES: ALARM SET INCORRECTLY. PRIOR TO EVENT, STABLE R IJ ECMO FLOWS >1.3 AND STABLE L GROIN ECMO > 4.4 NOTED DURING MORNING HANDOFF REPORT WITH PM RN AND DURING "PRE-ROUNDS" WITH ALD RESIDENT. AROUND 0845 - NO FLOW ON R IJ ECMO CANNULA VISUALLY NOTICED WITH ANESTHESIOLOGIST DURING ICU ROUNDS, NO ALARMS AT THIS TIME. PERFUSIONIST ASSESSED AND REPORTED SEEING SEPARATION OF BLOOD/CLOT IN R IJ CANNULA. PATIENT HAS A KNOWN ATRIAL SEPTAL DEFECT (ASD). THROUGHOUT THE EVENT PATIENT WAS HEMODYNAMICALLY STABLE AND INTACT MENTAL STATUS. EMERGENT REMOVAL OF R IJ CANNULA PERFORMED BEDSIDE BY MD. PATIENT RECEIVED 30MCG EPINEPHRINE IV PUSH FOR CARDIAC SUPPORT AND 125MCG OF FENTANYL. PATIENT HEMODYNAMICALLY TOLERATED THE DECANNULATION. LOW FLOW ALARM OR NO FLOW ALARM WOULD HAVE BEEN USEFUL IN THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686091 TRANSONIC FLOWMETER, BLOOD, CARDIOVASCULAR DPW TRANSONIC SYSTEMS INC. HT110 HT110

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA